Verification and Validation Engineer
Tucson, Arizona, US - 85755 Tucson, AZ 85755
Job Title: Verification And Validation Engineer
Location: Tucson, Arizona, US - 85755
Job Type: Contract
Duration: 12+ Months
About Our Client: Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives
- Mechanical Engineer with 7+ years in Verification & Validation, DHF Remediation, IVDR
- Knowledge / experience on medical device design controls / DHF remediation and MQMS process - ISO 13485 / ISO 14971
- Lead the definition, design, and execution of system V&V activities throughout the product development life cycle
- Development, implements, and maintains V&V strategies, objectives, short- and long-range planning; develops tracking and evaluation programs and project deliverables, and provide update to project teams.
- Creates, reviews and approves V&V deliverables with project team members.
- Ensure the requirements and specifications of the system can be verified and validated, by reviewing use cases, regulatory requirements, risk mitigations and usability.
- Conduct V&V Design Reviews as specified in project plans, and in accordance with customer procedure.
- Execute complex testing, perform in-depth statistical analysis, and interpret results independently.
- Ensure that testing and results are traced to requirements; activities are completed with objective evidence. Summarize results in reports with conclusions or recommendations and submits to project teams and management for appropriate decision
- Participates in project planning, process updates, and experimental design
- Extensive knowledge of testing principles and concepts
- Maintain knowledge of current regulatory requirements and standards as they pertain to the development and testing of medical/IVD devices
- Develop process solutions by identifying, testing, and controlling factors that influence product performance and manufacturability
- Strong knowledge of Quality System regulations (FDA 21CFR Part 820, ISO 13485, GDP etc)
- Experience in preparing DHF documentation, regulatory submissions, and other technical writing include operating manuals, SOP, IQ/OQ/PQ
- Provide coaching to other V&V engineers for designing test strategies and test cases
- Proven record of interpersonal skills to coordinate with client and offshore team, result oriented, self-driven and good communication skills
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities
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Recruiter: Jeff Kasula